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HANH TRIEU

ac1t8v@r.postjobfree.com

925-***-****

OBJECTIVE

Seeking for Software QA position to utilize training and experience in FDA regulation. SUMMARY

Accomplished and energetic, over seventeen years of cumulative experience in the in-vitro Diagnostic and Pharmaceutical industry including: QC, QA, V&V systems test, IOQ equipment & facility in Manufacturing, Engineering and New Product Development.

Collaborated with New Product Development engineering to conduct prototype and experimental runs of products or processes.

Developed, executed and summarized reports for design verification system testing, software application testing system, characterization and reliability testing, IOQ Equipment and facility.

Reviewed, analyzed and evaluated performance components and data analysis.

Familiar with design history file and risk management relating to Verification and Validation tests.

Created, followed and implemented with SOP's and DOP's.

Internal/Field Parts Failure Investigations. Analyzed factory nonconformity, field reliability data to recommend CAPA. Complete investigation report and CAPA plan. TECHNICAL SKILLS

Platforms and Software: Windows 10, Word, Excel, Solid Work, UNIX Perl and Shell.

Database: ASK, GQMS, Study Manager, ETQ Reliance, I-Plan,), ADST (Analysis Data System tester), CAN Messages Sniffer, DCO, ECO, Track Wise, Compliance Wire, Veeva Vault and SAP.

Experienced in testing embedded software for medical device/system (Software with Hardware device).

Experienced in functional V&V system testing, regression, reliability and characterization.

Developed and Executed Equipment/Facility qualification (IQ, OQ, PQ).

Defect Tracking Tools: JIRA and TFS (Team Foundation Server).

Familiar and knowledge in QA tools: Black box and automated testing.

Experienced with blood handling, wet chemistry and labs experiment, reagent and QC instrumentation.

Familiar with investigation tools: 5 M’s, Is/ Is Not and Fish Bone diagram.

Experienced in cGMP, GLP and GDP.

Hands-on Medical device with knowledge of FDA, QSR, IVDD, ISO 9001 and ISO 13485 (21 CFR Part 820, 11, 210.1 (a) and 211).

PROFESSIONAL EXPERIENCE

QA Validation, Impax Laboratories, Hayward, CA Jul 2016 – Apr 2017 Developed and completed Installation Operation Qualification for equipment and facilities in Pilot Plant and Packaging areas (Pharmaceutical).

Created trace matrix to map requirements in specification documents for protocol test scripts.

Developed User Requirements Specification (URS) and Impact Assessment documents for processing equipment in accordance to Validation plan.

Conducted the IOQ requalification protocols test scripts for Equipment and facility areas (GMP Pilot Plant area).

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Generated Commissioning IOQ qualification protocols for Packaging Facility area.

Routed IOQ and Commissioning Qualification protocols for approval.

Executed IOQ requalification and Commissioning Qualification in accordance to URS.

Analyzed validation test data to determine Equipment/Facility meeting validation criteria.

Identified and reported deviations/discrepancy from process protocol failures.

Prepared summary reports based on results of IOQ and Commissioning Qualification protocols.

Created requalification Review Summary Reports for processing equipment to support periodic review of all systems to remain in compliance and in a validated state. Quality V&V Engineer, Bio-Rad Laboratories, Hercules, CA Apr 2013 – Dec 2014 Supported NPD to launch Clinical Diagnostic product A1с system High Performance Liquid Chromatography (HPLC).

Implemented and executed test plan and reliability testing system (D100 system).

Conducted performance characteristics of the D-100 system according to specific failure rate.

Performed module testing (Fluidic Test and Bulk Fluidic test) according to the Module Test Plan.

Executed Design Verification protocols for functional testing system and chemistry behavior meeting specified DIPRs included: Feasibility (Smoke), Formal, Regression, α version, β version and Final release testing.

Performed troubleshooting of system during Verification & Validation activities.

Prepared blood bank samples and diluted blood to run chemistry testing on systems.

Collected, analyzed, recorded, documented data from expected test results.

Identified and documented problems with application program function, output and GUI screen content.

Documented and completed deviation report in the process execution.

Reviewed, evaluated and summarized Design Input Product Requirements assessment.

Wrote summary report for conclusion verification testing.

Provided feedback verification protocols test results to developer on hardware/software usability and functionality.

Worked and interfaced with Hardware, Software, Firmware, Material, Electromechanical Engineers and other QA Engineers in an agile team environment. Validation Engineer, Abbott Labs, Santa Clara, CA Jan 2007 – Oct 2010 Responsible for validating systems, RoHs components, and test procedures for On-market Engineering.

Organized, conducted and created engineering protocol for Cell-Dyne Sapphire V/V studies and Experiments.

Set up system and executed engineering protocols/experiments.

Prepared blood samples from biological fluids (e.g. plasma and serum) to test chemistry on systems.

Analyzed data, interpreted experimental data analysis and evaluated performance of components.

Documented test results and created Non-conformity report for failures.

Reviewed and wrote summary reports for Engineering protocols and experiments.

Compiled data package and circulated Final Engineering protocol data package for approval.

Opened change control documentation to bring existing components into alignment with completed studies.

Developed Laboratory Operation procedure to maintain instruments and equipment in engineering laboratory.

Run daily QC and calibrated the system to maintain ready state. Page 3 of 3

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Performed routine lab maintenance and preventive maintenance. Repaired and performed troubleshooting the system down to component level when the system was out of specification.

Planned and scheduled other group members to access/to utilize lab instruments.

Scheduled and coordinated validation projects with multiple engineering and operations groups including Planning, Manufacturing, Manufacturing Engineering, and New Product Development.

Provided validated test procedures in manufacturing (Electrical & Functional Test).

Trained production personnel in new and existing methods/procedures.

Resolved quality issues related non-conformance reports, complaints handling, Internal/Field Parts Failure Investigations and complete report and CAPA plan. Sr. Quality Control Associate, Abbott Labs, Santa Clara, CA Apr 1994 – Jan 2007 Followed and implemented Quality system for manufacturing/laboratory activities (Cell Dyne Chemistry Hematology Analyzers: CD Sapphire, CD 4000, CD 3700, CD 3200, CD Ruby and CD 1800).

Supported NPD and Advance Engineering by conducting tests for dry runs, feasibility prototype tests and Verification & Validation testing.

Assisted NPD with hardware upgrades, flow script changes and software changes.

Executed system test cases, system test scenarios, black box testing, and automated testing.

Documented software defects, re-tested treated defects, reviewed and summarized completed tests.

Performed system test for Root Cause Identification and product improvement.

Set up, visual inspected, aligned and tested electrical, electromechanical, sample processor, optical and autoloader.

Read blueprints, schematics, diagrams for troubleshooting system.

Tested and calibrated electrical system to meet operational specifications.

Prepared blood samples and aliquoted blood volumes to test CD Chemistry analyzer.

Executed functional QC test to release of commercial final product.

Supported investigations and troubleshoot issues related to instruments and methods out of specification results.

Documented test results per cGMP and initiated discrepancies system failures in NCR.

Reviewed and approved final test document package, device history records, line clearance, log book and labels summary per cGMP compliance.

Maintained and monitored control charting of laboratory humidity/temperature.

Ordered and maintained laboratory reagents inventories. Performed data storage and archives. EDUCATION AND TRAINING

California State University East Bay Hayward, CA

Bachelor of Science: Biomedical Technology Dec 1994 Software Advanced Technology Institute Sunnyvale, CA Certificate: SQA Jun 2000

Technical Training Learning College San Jose, CA

Certificate: Solid works For Mechanical Design and Drafting Oct 2015

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